Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation

Breast Cancer Clinical Trial

Official title:

Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02958774
• Other study ID #: IIT-2017-MM-BRST-HypoFracRT
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: March 1, 2029

Study information

• Verified date: June 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to document lymphedema rates in patients requiring regional nodal irradiation (RNI) who receive hypofractionated radiation as compared to conventional radiation.

Description:

Participants with stage II or stage III node-positive breast cancer, or T3N0 node-negative will receive hypofractionated radiation for 4 weeks. We hypothesize that patients receiving a shorter course of radiation will have reduced lymphedema. Lymphedema is diagnosed when the patient's arm circumference measures 10% or more as compared to pre-treatment (baseline) arm circumference measurement. Secondary endpoints will address the effectiveness, quality of life, and side effect profile of a shortened course of treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 388
• Est. completion date: March 1, 2029
• Est. primary completion date: January 6, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Karnofsky Performance Status 50% - 100%

• Diagnosis of stage II or III node-positive breast cancer (NOTE: Stages include:

T4a-cNany, T3N1, TxN2.) OR T3N0 node-negative breast cancer.

• For patients with TxN1 disease, one of the following criteria must be met: Grade 3; = 45 years of age at time of screening for this study; extensive Lymphovascular Space Invasion (LVSI); 3 lymph nodes positive; hormone-negative disease; positive lymph nodes after chemotherapy; or extracapsular extension

• Prior surgery and chemotherapy allowed, no prior radiation to the target area (breast or chest and nodes). NOTE: Radiation should occur 3-12 weeks after last chemotherapy or surgery, whichever comes last.

• Women of child-bearing potential (WOCP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

Exclusion Criteria:

• Diagnosis of inflammatory breast cancer

• Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more)

• Diagnosis of scleroderma

• Diagnosis of lupus

• Diagnosis of active dermatomyositis

• Diagnosis of metastatic disease

• Pregnant or nursing

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Hypofractionated Radiation Therapy
Chest/Breast 4005 centigray (cGy)/15 fractions/267 cGy daily Regional nodes 4005 cGy/15 fractions/267 cGy daily 1000 cGy boost to lumpectomy/scar/undissected nodes 200 cGy daily

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphedema Rate	Defined as a 10% increase in arm circumference from pre-treatment (baseline) arm circumference measurement.	One year post end of treatment (EOT)
Secondary	Local Recurrence	Defined as biopsy proven recurrence of breast cancer involving the chest wall, breast, axilla, internal mammary or supraclavicular nodes	12 months post-EOT
Secondary	Cosmetic (Breast) Outcome	Measured using the Breast Q™ Assessment questionnaire	12 months post-EOT
Secondary	Quality of Life	Measured using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) questionnaire	After enrollment but prior to CT simulation; 14-90 days post-EOT; 12 months post-EOT
Secondary	Range of Motion (Upper Extremities)	Percent reduction in referrals to physical therapy for impaired range of movement post-EOT	14-90 days post-EOT; 6 months post-EOT; 12 months post-EOT